Medical devices

 

  • Advising a US company on clinical trials for tissue products and on product classification issues pursuant to the new EU Medical Devices Regulation 2017/745
  • Adapting various OEM-QS and Responsible Person agreements to the legal requirements stipulated in the new EU Medical Devices Regulation 2017/745
  • Advising an international medical devices distributor on the sponsorship of events for physicians and existing legal boundaries due to anti-corruption regulations and industry codes.
  • Advising an Austrian health products company on the switch of various products that are no longer marketable as medical devices under the new EU Medical Devices Regulation.
  • Preparation of various clinical trial contracts for medical devices and in-vitro diagnostics companies
  • Advising a distributor of foot care products on the product switch from cosmetic products to medical devices
  • Comprehensive consulting for a Canadian manufacturer of high-quality kinesiology tapes in European medical device law (e.g. preparation of documents for the conformity assessment procedure, for advertising and labelling of the respective products)
  • Advising a manufacturer of innovative corneal cross-linking products on specific regulatory and strategic issues in the field of European medical devices law
  • Advising a PE investor/spin-off of a medical device manufacturer on a complex development contract for respiratory therapeutics
  • Regular advice to manufacturers of medical devices in the fields of dental products, prostheses and material medical devices in the field of therapeutic products advertising law

 

Industry all-rounder"
JUVE Handbook 2018/2019
"Frequently recommended lawyer" in food law
JUVE Handbook 2018/2019
"Open and fair, professionally well-versed"
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